6种脂蛋白(a)免疫测定法在评价动脉粥样硬化心血管疾病中的临床应用  

Clinical application of six different lipoprotein(a)immunoassays in evaluating atherosclerotic cardiovascular disease

作　　者：朱旭 钟远红 王健[1] 程歆琦[1] ZHU Xu;ZHONG Yuanhong;WANG Jian;CHENG Xinqi(Department of Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Medical Science,Beijing 100730;Shenzhen Mindray Biomedical Electronics Co.,Ltd,Shenzhen 518057,Guangdong,China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730 [2]深圳迈瑞生物医疗电子股份有限公司,广东深圳518057

出　　处：《临床检验杂志》2025年第4期253-260,共8页Chinese Journal of Clinical Laboratory Science

摘　　要：目的对6种脂蛋白(a)[Lp(a)]免疫测定法检测系统进行性能验证,对比不同检测系统测定结果的相关性和一致性,并探讨其在评价动脉粥样硬化心血管疾病(AsCVD)中的临床应用。方法回顾性选择北京协和医院就诊的AsCVD患者150例作为研究对象,选取同期健康体检者50例作为健康对照组。对200例血清样本分别使用6种检测系统进行Lp(a)水平测定,其中包括2种以nmol/L为单位的Lp(a)颗粒浓度测定法(罗氏和迈瑞Ⅱ),和4种以mg/L为单位的Lp(a)质量浓度测定法(迈瑞、美康、九强和积水)。所有检测方法均进行精密度评价。将各检测系统测定结果与Lp(a)测定平均值相比较,绘制Passing-Bablok回归分析图和Bland-Altman偏倚图以评估检测准确度,采用一致性相关系数(CCC)分析不同系统间的一致性。此外,不同检测方法在临床上评估AsCVD的一致性使用加权Kappa统计方法进行比较,同时评估研究组和健康对照组Lp(a)颗粒浓度、质量浓度的阳性率及Lp(a)质量浓度高估率和低估率。结果6种Lp(a)检测方法的精密度为0.6%~2.1%。Passing-Bablok回归分析显示,各回归方程的Spearman相关系数均>0.970,回归直线的截距和斜率分别为-43.311~39.456.0.547~5.500。Bland-Altman偏倚图显示,6种检测方法与Lp(a)测定平均值的平均相对偏差在-25.939%~40.205%。Lp(a)质量浓度检测系统中迈瑞、美康结果呈正偏差,九强、积水结果呈负偏差。一致性分析显示,与Lp(a)平均值相比,罗氏和迈瑞Ⅱ具有极好的一致性(CCC:0.992~0.993);迈瑞、美康和九强具有较好的一致性(CCC:0.950~0.986),积水具有中度一致性(CCC:0.935)。研究组中Lp(a)阳性率由大到小依次为美康>九强>迈瑞>罗氏=迈瑞Ⅱ>积水。不同组别中迈瑞、美康、九强和积水相较于Lp(a)颗粒浓度测定法的总符合率分别为97.33%、93.33%、97.33%和98.00%,Kappa值分别为0.910.0.798、0.912和0.927。结论2种Lp(a)颗粒浓度测定法相�Objective To validate the performance of six different lipoprotein(a)[Lp(a)] immunoassay detection systems,compare the correlation and consistency of the measurement results of dfferent detection systems,and explore their clinical application in the evaluation of atherosclerotic cardiovascular disease(AsCVD).Methods A total of 150 AsCVD patients attending Peking Union Medical College Hospital were retrospectively selected as the subjects of study group,and 50 individuals of physical examination during the same period were selected as healthy control group.Lp(a)levels were measured in 200 serum samples using six immunoassay detection systems,including two Lp(a)particle concentration assays in nmol/L(Roche and Mindray Ⅱ),and four Lp(a)mass concentration assays in mg/L(Mindray,MedicalSystem,BSBE,and Sekisui).All assays'precisions were evaluated.The results of each assay system were compared with the mean value of all the Lp(a)assays.Passing-Bablok regression analysis and Bland-Altman bias plots were used to assess the accuracy of assays,and the consistency between different systems was analyzed using the concordance correlation coefficient(CCC).In addition,the consistencies of different assays in assessing AsCVD in clinical setting were compared using weighted Kappa statistical method,and the positive rates of Lp(a)particle concentration and mass concentration,as well as the overestimation and underestimation of mass concentration were also assessed for both the study group and the healthy control group.Results The precision of the six Lp(a)assays ranged from 0.6%to 2.1%.Passing-Bablok regression analysis showed that the Spearman correlation coefficients of the regression equations were all greater than 0.970,and the intercepts and slopes of the regression lines were-43.311 to 39.456 and 0.547 to 5.500,respectively.The Bland-Altman bias plots showed that the percent bias of the six assays compared to the mean value of Lp(a)determination was in the range of-25.939%to 40.205%.The results of the Lp(a)mass concentrati

关 键 词：脂蛋白(a) 免疫测定法 方法学评价 动脉粥样硬化心血管疾病 

分 类 号：R446[医药卫生—诊断学]